A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Recruiting
Phase 2Interventional Study
Geographic Atrophy of the Macula
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
Galimedix Therapeutics Inc · Industry
Who this trial is looking for
This trial is looking for older adults with a specific eye condition. Participants will use eye drops daily to see if the new medication helps slow the progress of their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 55 years old.
I can give written consent.
I can follow the study schedule.
I can use eye drops myself or have someone who can help me.
I have a visual acuity of 20/100 or better in my study eye.
I have been diagnosed with Geographic Atrophy in my study eye.
I have a specific amount of area affected in my study eye.
You may not be able to join if
I have a history of certain eye conditions like choroidal neovascularization.
I have had laser treatment in my macula before.
I have had eye surgery in the last 3 months.
I have certain other eye diseases that could affect my participation.
I am pregnant, nursing, or planning to become pregnant.
I have a history of active eye infections in the past 3 months.
I cannot use an acceptable form of contraception if I can become pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp c…
Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* ≥55 years of age
* Willing and able to provide written informed consent
* Willing and able to comply with the study schedule and study assessments
* Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care profession…
Inclusion Criteria:
* ≥55 years of age
* Willing and able to provide written informed consent
* Willing and able to comply with the study schedule and study assessments
* Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution
* BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline
* Refractive error between +3 and -6 diopters spherical equivalent in the study eye
* Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline
* Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center
1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2
2. If GA is multifocal, at least 1 lesion ≥1.25 mm2
3. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \[RPE\] and outer retina)
4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea
5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \>300 µm from image edges
6. GA lesions must be \>300 µm from the optic disc and/or peripapillary atrophy
7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2
Exclusion Criteria:
1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
2. History of laser therapy in the macular region, regardless of indication
3. History of herpes zoster
4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period
5. GA with cumulative area \<1.25 mm2
6. Any GA lesion within 100 µm radius from the center point of the fovea
7. Axial length \>26 mm
8. Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)
9. Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period
10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period
11. Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period
12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period
Non-study Eye:
13. BCVA of \<5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
Either Eye:
14. History of uveitis
15. GA secondary to any condition other than non-neovascular AMD
16. History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline
17. Underwent investigational treatment for AMD within 6 months before Visit 1a
General Exclusion Criteria:
18. History of therapeutic radiation to the cranium
19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients
20. History of malignant disease
21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period
22. Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period
23. Use of lutein \>10 mg per day or zeaxanthin \>2 mg per day within 1 month before Visit 1a, or planned use during the study period
24. Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data
25. Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation
26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline
27. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.